Veltassa is a drug owned by Vifor Pharma Inc. It is protected by 13 US drug patents filed from 2015 to 2023. Out of these, 7 drug patents are active and 6 have expired. Veltassa's patents have been open to challenges since 22 October, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 08, 2033. Details of Veltassa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8337824 | Linear polyol stabilized polyfluoroacrylate compositions |
May, 2030
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9492476 | Potassium-binding agents for treating hypertension and hyperkalemia |
Oct, 2033
(7 years from now) | Active |
| US11123363 | Potassium-binding agents for treating hypertension and hyperkalemia |
Oct, 2033
(7 years from now) | Active |
| US9925212 | Potassium-binding agents for treating hypertension and hyperkalemia |
Oct, 2033
(7 years from now) | Active |
| US8147873 | Methods and compositions for treatment of ion imbalances |
Jun, 2028
(2 years from now) | Active |
| US8282913 | Ion binding polymers and uses thereof |
May, 2027
(1 year, 7 months from now) | Active |
| US8216560 | Ion binding polymers and uses thereof |
Mar, 2027
(1 year, 4 months from now) | Active |
| US7556799 | Ion binding polymers and uses thereof |
Feb, 2025
(7 months ago) |
Expired
|
| US10485821 | Ion binding polymers and uses thereof |
Mar, 2024
(1 year, 6 months ago) |
Expired
|
| US8889115 | Ion binding polymers and uses thereof |
Mar, 2024
(1 year, 6 months ago) |
Expired
|
| US8287847 | Ion binding polymers and uses thereof |
Mar, 2024
(1 year, 6 months ago) |
Expired
|
| US8778324 | Ion binding polymers and uses thereof |
Mar, 2024
(1 year, 6 months ago) |
Expired
|
| US8475780 | Ion binding polymers and uses thereof |
Mar, 2024
(1 year, 6 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Veltassa's patents.
Latest Legal Activities on Veltassa's Patents
Given below is the list of recent legal activities going on the following patents of Veltassa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Jun, 2024 | US8337824 |
| Maintenance Fee Reminder Mailed
Critical | 03 Jun, 2024 | US8287847 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Apr, 2024 | US8282913 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jan, 2024 | US8216560 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8147873 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 May, 2023 | US10485821 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 May, 2022 | US8889115 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jan, 2022 | US8778324 |
| Post Issue Communication - Certificate of Correction | 25 Oct, 2021 | US11123363 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Sep, 2021 | US9925212 |
FDA has granted several exclusivities to Veltassa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Veltassa, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Veltassa.
Exclusivity Information
Veltassa holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Veltassa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 21, 2020 |
| New Patient Population(NPP) | Oct 02, 2026 |
| New Strength(NS) | Oct 02, 2026 |
Several oppositions have been filed on Veltassa's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Veltassa's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Veltassa patents.
Veltassa's Oppositions Filed in EPO
Veltassa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 18, 2016, by Hexal Ag. This opposition was filed on patent number EP09748557A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09748557A | Apr, 2016 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
| EP09748557A | Apr, 2016 | Hexal AG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Veltassa is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Veltassa's family patents as well as insights into
ongoing legal events
on those patents.
Veltassa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Veltassa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 08, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Veltassa Generics:
There are no approved generic versions for Veltassa as of now.
How can I launch a generic of Veltassa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Veltassa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Veltassa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Veltassa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 8.4 g, 16.8 g and 25.2 g | 21 Oct, 2019 | 2 | 08 Oct, 2033 |
About Veltassa
Veltassa is a drug owned by Vifor Pharma Inc. It is used for lowering high levels of potassium in the blood. Veltassa uses Patiromer Sorbitex Calcium as an active ingredient. Veltassa was launched by Vifor Pharma in 2023.
Approval Date:
Veltassa was approved by FDA for market use on 02 October, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Veltassa is 02 October, 2023, its NCE-1 date is estimated to be 22 October, 2019.
Active Ingredient:
Veltassa uses Patiromer Sorbitex Calcium as the active ingredient. Check out other Drugs and Companies using Patiromer Sorbitex Calcium ingredient
Treatment:
Veltassa is used for lowering high levels of potassium in the blood.
Dosage:
Veltassa is available in powder form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 16.8GM BASE/PACKET | POWDER | Prescription | ORAL |
| EQ 25.2GM BASE/PACKET | POWDER | Discontinued | ORAL |
| EQ 1GM BASE/PACKET | POWDER | Prescription | ORAL |
| EQ 8.4GM BASE/PACKET | POWDER | Prescription | ORAL |